Tissue adjustment implant

ABSTRACT

Tissue adjustment implants useful for adjusting a position of tissue in a patient are described. In an embodiment, a tissue adjustment implant includes a main body having a series of outwardly-extending projections. The tissue adjustment implants can be used in a variety of treatments, such as in the treatment of Obstructive Sleep Apnea and snoring.

RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/449,195, filed on Aug. 1, 2014 and which claims the benefit of U.S.Provisional Application No. 61/861,089, filed on Aug. 1, 2013. Thedisclosure of each of these related applications is hereby incorporatedinto this disclosure in its entirety.

FIELD

The disclosure relates generally to the field of implantable medicaldevices. Particular embodiments relate to tissue adjustment implants.

BACKGROUND

It is sometimes necessary or desirable to secure a tissue or portion ofa tissue within the body of an animal, such as a human, in a manner thattemporarily or permanently adjusts a position or orientation of thetissue or portion of a tissue. For example, in the treatment ofObstructive Sleep Apnea (OSA), it may be desirable to adjust theposition of one or more tissues or portions of tissue, such as the softpalate.

OSA is a clinical disorder in which a partial or complete collapse ofsoft tissue occurs in the airway during sleep. This leads to a blockageof the airway and impaired breathing during sleep. Mild OSA can lead tofatigue, reduced alertness following sleep, and a general reduction inproductivity for the affected individual. Severe OSA can lead to sleepdeprivation, hypoxemia, and depression.

The art provides various options for the treatment of OSA. ContinuousPositive Airway Pressure (CPAP) machines, which supply positive airpressure through a facemask and into the airway during sleep, are usedmost frequently. The positive air pressure maintains an open airway toprevent apnea and snoring. While these machines are generally consideredeffective, they are bulky, noisy, and cumbersome to use. Furthermore,use of these machines can be socially awkward for some individuals.

Oral appliances that force the jaw forward to maintain an open airwaycan also be used. These devices are generally considered to be not aseffective as CPAP machines, and can be uncomfortable to use.Furthermore, these devices are frequently ejected from the mouth duringsleep, reducing their effectiveness over the entire course of a sleepingperiod.

Invasive surgical procedures can also be used to treat OSA. Varioustechniques have been described, including uvulopalatopharyngoplasty(UPPP), maxillomandibular advancement (MMA), and even tracheostomy.Surgical procedures are generally considered to have limited andpotentially short-lived effectiveness. Furthermore, many of theprocedures require hospitalization and the use of general anesthesia. Asa result, these procedures are generally reserved for severe cases ofOSA.

The AIRvance™ System from Medtronic, formerly known as the ReposeSystem, provides a surgical-based tongue suspension procedure that canbe performed with or without an adjunct hyoid suspension procedure.These suspension procedures require a surgical incision and dissectionof the neck below the mandible. Following implantation of one or morenecessary bone screws, sutures are lashed around the tongue and/or hyoidbone and secured with surgical knots. While these procedures offer lesscomplicated solutions than the surgical procedures above, they stillrequire surgical intervention and suffer from the drawbacks associatedwith surgical procedures. Furthermore, over time, the sutures used tosuspend the tongue and/or hyoid bone may weaken or even snap, which maylimit the effectiveness of the treatment over time. Lastly, the use ofsutures in these procedures necessitates the use of specialized knottingand securement techniques to complete the procedure, which adds anadditional opportunity for error and failure in the device and theprocedure.

Considering the disadvantages of the various available treatment optionsdescribed above, a need exists for improved devices for adjustment oftissue within the body. Furthermore, a need exists for additionaloptions, including implantable medical devices, for the treatment ofOSA.

DESCRIPTION OF FIGURES

FIG. 1 is a perspective view of an embodiment of a tissue adjustmentimplant.

FIG. 2 is a perspective view of another embodiment of a tissueadjustment implant.

FIG. 2A is a magnified view of area I indicated in FIG. 2.

FIG. 3A is a perspective view of another embodiment of a tissueadjustment implant.

FIG. 3B is a perspective view of another embodiment of a tissueadjustment implant.

FIG. 3C is a perspective view of another embodiment of a tissueadjustment implant.

FIG. 3D is a perspective view of another embodiment of a tissueadjustment implant.

FIG. 3E is a perspective view of another embodiment of a tissueadjustment implant.

FIG. 3F is a perspective view of a projection member isolated from theimplant illustrated in FIG. 3E.

FIG. 4A is a perspective view of another embodiment of a tissueadjustment implant.

FIG. 4B is a perspective view of another embodiment of a tissueadjustment implant.

FIG. 4C is a perspective view of another embodiment of a tissueadjustment implant.

FIG. 4D is a perspective view of another embodiment of a tissueadjustment implant.

FIG. 4E is a perspective view of another embodiment of a tissueadjustment implant.

FIG. 5 is a schematic of an oral cavity of a patient within which twotissue adjustment implants have been placed.

FIG. 6 is a top view of another embodiment of a tissue adjustmentimplant.

FIG. 6A is an elevation view of the tissue adjustment implantillustrated in FIG. 6.

FIG. 6B is another elevation view of the tissue adjustment implantillustrated in FIG. 6.

FIG. 7 is a top view of another embodiment of a tissue adjustmentimplant.

FIG. 8 is an elevation view of a delivery device for implanting a tissueadjustment implant.

FIG. 9 is a magnified view of area II illustrated in FIG. 8.

FIG. 10 is a sectional view of the cannula of the delivery deviceillustrated in FIG. 9, taken along line 10-10.

FIG. 11 is a sectional view of the cannula of the delivery deviceillustrated in FIG. 9, taken along line 11-11.

FIG. 12 is a partial top view of the delivery device illustrated in FIG.9. A tissue adjustment implant is loaded in the cannula of the deliverydevice.

FIG. 13 is a schematic of an oral cavity of a patient within which twotissue adjustment implants have been placed.

DESCRIPTION OF EMBODIMENTS

The following detailed description and the appended drawings describeand illustrate various example embodiments. The description andillustration of these examples are provided to enable one skilled in theart to make and use a tissue adjustment implant. They are not intendedto limit the scope of the claims in any manner.

FIG. 1 illustrates an example of a tissue adjustment implant 10. Thetissue adjustment implant 10 has a main body 12 comprising asubstantially flat member extending from a first end 14 to an opposingsecond end 16 and having first 18 and second 20 opposing sides. The mainbody 12 has a first 22 or upper surface and an opposing second 24 orlower surface.

The main body 12 has a lengthwise axis 26 and a transverse axis 28 thatorthogonally intersects the lengthwise axis 26 at a longitudinalmidpoint 30 disposed on the lengthwise axis 26. A first anchor portion32 extends along the lengthwise axis 26 of the main body 12 from a pointon the lengthwise axis 26 between the longitudinal midpoint 30 and thefirst end 14 to the first end 14. Similarly, a second anchor portion 34extends along the lengthwise axis 26 of the main body 12 from a point onthe lengthwise axis 26 between the longitudinal midpoint 30 and thesecond end 16 to the second end 16. A middle portion 36 extends alongthe lengthwise axis 26 of the main body 12 across the longitudinalmidpoint 30 from an end of the first anchor portion 32 to an end of thesecond anchor portion 34.

The first anchor portion 32 defines a first series of projections 38.Similarly, the second anchor portion 34 defines a second series ofprojections 40. Each of the first 38 and second 40 series of projectionsincludes a series of projections that extend outwardly from therespective side 18, 20 of the main body 12, away from the longitudinalaxis 26. The middle portion 36 is free of outwardly extendingprojections.

As used herein, the term “projection” refers to an outwardly-directedmember or portion of a member that extends away from a surface ofanother member or another portion of a member. An individual projectioncan have any suitable shape, including regular and irregular shapes,symmetrical and asymmetrical shapes, and any other suitable shape. Theterm “series of projections” refers to two or more individualprojections. A series of projections includes multiple projectionshaving the same shape, size and or/configurations, a series ofprojections having different sizes, shapes and configurations, a seriesof projections spaced at regular intervals, such as a toothed surface, aseries of projections spaced at different intervals, and a series ofprojections spaced at irregular intervals. The illustrated embodimentincludes a series of projections extending away from each side 18, 20 ofthe main body in each series of projections 38, 40. It is understood,though, that any suitable number of projections can extend away fromeach side 18, 20 of the main body 12 in a series of projections,including one projection, two projections, three projections, or more.Indeed, the number of projections that extend away from a side 18, 20 ina series of projections need only be at least one projection.Furthermore, it is noted that a series of projections can include one ormore projections that extend away from only one of the sides 18, 20 ofthe main body 12 or away from both of the sides 18, 20 of the main body12.

In the illustrated embodiment, each projection 42 of the first series ofprojections 38 is substantially triangular in shape and extends awayfrom the longitudinal axis 26 and away from the first end 14 of the mainbody 12 toward the transverse axis 28. Similarly, each projection 44 ofthe second series of projections 40 is substantially triangular in shapeand extends away from the longitudinal axis 26 and away from the firstend 14 of the main body 12 toward the transverse axis 28.

In the illustrated embodiment, a projection 46 of the first series ofprojections 38 that is farthest from the longitudinal midpoint 30 has aside 48 that is continuous with the first end 14 of the main body 12.Similarly, a projection 50 of the second series of projections 40 thatis farthest from the longitudinal midpoint 30 has a side 52 that iscontinuous with the second end 16 of the main body 12.

Inclusion of the opposing series of projections 38, 40 is consideredadvantageous at least because each series 38, 40 provides an anchor atan end of the tissue adjustment implant 10 that is opposite an end ofthe implant that is first inserted into the tissue. Once the tissueadjustment implant 10 is then passed through the tissue, the series ofprojections at the opposite end are able to engage the tissue and, uponthe application of additional force on the tissue engaging implant, suchas tension, the position of the tissue can be adjusted, such as bylifting or otherwise moving the tissue, as described more fully below.As an example, described in greater detail below, the tissue adjustmentimplant can be used to engage and adjust the position of the soft palateof a patient, such as in the treatment of Obstructive Sleep Apnea.

In the illustrated embodiment, the first 22 and second 24 surfaces ofthe main body 12 are substantially flat. It is noted, though, that itmay be advantages to include one or more bumps, projections or othersurface modifications on one or both of the surfaces 22, 24. Inclusionof such modifications may improve the handling of the tissue adjustmentimplant 10 during use.

FIGS. 2 and 2A illustrate another tissue adjustment implant 110. In thisembodiment, the tissue adjustment implant 110 comprises a main body 112comprising a substantially flat member extending from a first end 114 toan opposing second end 116 and having first 118 and second 120 opposingsides. The main body 112 has a first 122 or upper surface and anopposing second 124 or lower surface. The main body 112 has a lengthwiseaxis 126 and a transverse axis 128 that orthogonally intersects thelengthwise axis 126 at a longitudinal midpoint 130 disposed on thelengthwise axis 126. An anchor portion 136 extends along the lengthwiseaxis 126 of the main body 112 across the longitudinal midpoint 130. Afirst end portion 132 extends from an end of the first anchor portion132 to the first end 114 of the main body 112. A second end portion 134extends from the opposite end of the anchor portion 132 to the secondend 116 of the main body 112.

In this embodiment, the anchor portion 136 defines a first series ofprojections 138 and a second series of projections 140. Each of thefirst 138 and second 140 series of projections includes a series ofprojections that extend outwardly from the respective side 118, 120 ofthe main body 112, away from the longitudinal axis 126. The first 132and second 134 end portions are free of outwardly extending projections.

As best illustrated in FIG. 2A, each projection 142 of the first 138 andsecond 140 series of projections is a wing-shaped member that extendsradially outward from a side 120 of the main body 112. The wing-shapedmember has a relatively wide base 160 that lies along a hypotheticalextension of the side 120 and a relatively narrow end 162 that lies onhypothetical line that is parallel to the side 120. As best illustratedin FIG. 2, each projection 142 of the first 138 and second 140 series orprojections extends away from the respective side 118, 120 and away fromthe first end 114 of the main body. In the illustrated embodiment, asbest illustrated in FIG. 2A, each projection 142 of the first 138 andsecond 140 series of projections extends away from the respective side118, 120 of the main body at an angle such that an obtuse angle α isformed on the side of the projection 142 that is closest the first end114 of the main body 112 and such that an acute angle β is formed on theside of the projection 142 that is closest the second end 116 of themain body 112. While any suitable configuration can be used for theprojections 142, this configuration facilitates placement and anchoring.

In this embodiment, the main body 112 defines a series of openings 164positioned along the lengthwise axis 126. Each opening of the series ofopenings 164 extends through the thickness of the main body 112 from thefirst surface 122 to the second surface 124. As such, each openingdefines a passageway that extends through the main body 112. In thisembodiment, as best illustrated in FIG. 2, the series of openings 164extends along the entire anchor portion 136 of the main body 112.

It is noted that any opening in the series of openings 164 can have oneor more dimensions that differ from the same dimension or dimensions ofanother opening in the series of openings 164 while also have one ormore dimension that is the same or substantially similar to the samedimension or dimensions of the other openings of the series of openings164. For example, each opening of the series of openings 164 may have arectangular shape, with one or more opening having a length and widththat differ from the length and width of one or more otherrectangular-shaped openings. Also, while the illustrated embodimentincludes a series of openings 164, it is noted that any suitable numberof openings can be included in a tissue adjustment implant according toa particular embodiment, including zero, one, two, three, or any othersuitable number of openings. Inclusion of one or more openingsfacilitates anchoring of a tissue adjustment implant followingimplantation.

In this embodiment, a lead 170 is attached to the first end 114 of themain body. The lead 170 provides a leading structure that can be used toform an opening in and/or introduce the tissue adjustment implant intotissue. As such, the lead 170 advantageously includes a portion that cancut into tissue. For example, in the illustrated embodiment, the lead170 comprises a needle 172 secured to a suture 174 that is attached tothe main body 112 near the first end 114. It is noted, though, that anysuitable lead structure can be used, including a cutting edge or pointthat is disposed in the first end of a main body of tissue adjustmentimplant.

In this embodiment, a plug 180 is disposed on the second end 116 of themain body 112. The plug 180 has a width 182 that is greater than a width184 of the main body 112 measured from one side 118 to the other 120. Inthe illustrated embodiment, the plug 180 is a separate member that hasbeen attached to the main body, such as by an adhesive or throughmechanical attachment. It is noted, though, that in other embodimentsthe plug can be integrally formed with the main body.

Inclusion of a plug on an end of the main body facilitates implantationof a tissue adjustment implant because it provides a mechanical stopthat impedes further passage of the tissue adjustment implant into thetissue once the plug has reached the point of entry into the tissue,such as an opening through which the remainder of the tissue adjustmentimplant has been passed. Also, by providing a mechanical stop thatimpedes further passage of the tissue adjustment implant, the inclusionof a plug facilitates the adjustment function of the tissue adjustmentimplant. For example, once the plug has reached the point of entry intothe tissue, a continued pulling on the tissue adjustment implant, suchas a continued pulling on lead attached to the first end of the mainbody or on the first end of the main body itself, will produce a pullingforce on the tissue surrounding the plug at the point of entry. This canbe used to lift, move or otherwise adjust the position of the tissuewithin the body through the application of a simple pulling force on thetissue adjustment implant.

Each of FIGS. 3A, 3B, 3C, 3D, and 3E illustrates a tissue adjustmentimplant that includes an alternative structure for a series ofprojections. FIG. 3A illustrates a tissue adjustment implant 210 thatincludes a flat main body 212 into which a series of projections 290 hasbeen formed by cutting through the thickness of the main body 212. Thisforms projections that can extend outward from one 222 or the other 224surfaces of the main body 212. Any suitable technique can be used toform the projections in this manner, including die cutting and lasercutting techniques. The specific technique selected for a particularembodiment with depend on various considerations, including the materialof the main body and the size and configuration of the projections.Laser cutting is a suitable technique for forming projections in a mainbody that comprises a flat sheet, such as a flat sheet of smallintestine submucosa. Additional projections extend radially outward fromthe sides 218, 220 of the main body 212.

Any suitable angle, length, shape and configuration can be used for theprojections. FIG. 3B illustrates a tissue adjustment implant 310 thathas projections that are similar in shape to those of the tissueadjustment implant 210 illustrated in FIG. 3A, but that are relativelylarger. In this embodiment, a series of projections 390 has been formedby cutting through the thickness of the main body 312. This formsprojections that can extend outward from one 322 or the other 324surfaces of the main body 312. Additional projections extend radiallyoutward from the sides 318, 320 of the main body 312.

FIG. 3C illustrates a tissue adjustment implant 410 that includes asubstantially round, elongate main body 412. A series of projections 490has been formed by cutting into the main body 412 at an angle to form awedge-shaped projection. Each projection of the series of projectionshas been pulled slightly away from the main body 412.

FIG. 3D illustrates a tissue adjustment implant 510 that includes aseries of projections 590 that is integrally formed with the main body512. Each projection of the series of projections comprises asubstantially circular-shaped body. In this embodiment, along with otherembodiments in which the projections are integrally formed with the mainbody, the projections can be formed during the process of forming themain body, such as in a molding technique.

FIG. 3E illustrates a tissue adjustment implant 610 in which a series ofseparate projection-defining members 690 have been passed over a mainbody 612. FIG. 3F illustrates a single projection-defining member 690isolated from the tissue adjustment implant. As best illustrated in thatFigure, each projection-defining member 690 defines outwardly-extendingprojections 692 and an opening 694. The tissue adjustment implant 610 isformed by passing the main body 612 through the opening 694 of each of aseries of projection-defining members 690. Once disposed on the mainbody 612, the projection-defining members can be rotated about itslengthwise axis to place the projections in an offsetting relationshipwith respect to each other. While a series of projection-definingmembers 690 is illustrated, it is noted that any suitable number can beused, including one, two, three or any suitable number. Also, while theillustrated projection-defining members 690 are star-shaped, anysuitable shape, size and configuration can be used, including anyconfiguration that provides the desired outwardly-extending projections.

It is noted that, while not illustrated in the Figures, any of thetissue adjustment implants illustrated in FIGS. 3A, 3B, 3C, 3D and 3Ecan include any suitable lead attached to the main body, as describedabove, as well as any suitable plug, as described above and below.

If included, the plug can have any suitable size, shape andconfiguration. Indeed, the plug in a tissue adjustment implant accordingto a particular embodiment need only have sufficient structure toprovide the desired mechanical stop, as described above. Each of FIGS.4A, 4B, 4C, 4D, and 4E illustrates a tissue adjustment implant thatincludes an example structure for a plug.

FIG. 4A illustrates a tissue adjustment implant 710 that includes a plug780 that is integrally formed with the main body 712 of the tissueadjustment implant 710. In this embodiment, the plug 780 has a stopperconfiguration, with a base 782, an end 784, and a frustoconical wall 786that extends between the base 782 and end 784. The base 782 and end 784are flat and parallel with each other.

FIG. 4B illustrates a tissue adjustment implant 810 that includes a plug880 that comprises a separate element that has been attached to the mainbody 812 of the tissue adjustment implant 810. In this embodiment, theplug 880 has a rounded button configuration, with a base 882 and arounded end 884 that meets the base 882 at outer edge 886 of the base882. The plug 880 can be attached to the main body 812 by forming anopening 888 in a section of material, such as excess material from theforming of the main body 812, and placing an end 816 of the main bodyinto the opening 888. An adhesive or other suitable agent for securingthe plug 880 to the main body 812, can be added to the connection, suchas in the opening 882, around an interface between the plug 880 and mainbody 812, or both.

FIG. 4C illustrates a tissue adjustment implant 910 that includes a plug980 that is integrally formed with the main body 912 of the tissueadjustment implant. In this embodiment, the plug 980 has a flattenedbutton configuration, with a base 982 and a rounded end 984 that meetsthe base 982 at a point that is radially inward from the outer edge 986of the base 982. This forms a circumferential shoulder 988 that extendsaround the plug 980 slightly inward from the outer edge 986 of the base982. The plug 980 can be formed with the main body 912 by including apartial spherical or other rounded chamber, adjacent a chamber ofappropriate size and configuration for forming the base 982, in theforming of the main body 912.

FIG. 4D illustrates a tissue adjustment implant 1010 that includes amain body 1012 formed of multiple sheets 1082, 1084 of material thathave been attached to each other. In this embodiment, the plug 1080comprises an end portion 1086 of the first 1082 sheet and an end portion1088 of the second 1084 sheet that have been separated from each otherand coated with a stiffening or other suitable agent, such as PLGA, tomaintain their separated position. In the illustrated embodiment, theend portions 1086, 1088 have been positioned at orthogonal angles to thelongitudinal axis of the main body 1012, but it is noted that anysuitable angle can be used, including a substantially orthogonal angle,an obtuse angle, and an acute angle. Also, it is noted that, whiledescribed as having been separated from each other after the sheets1082, 1084 have been attached to each other, the end portions 1086, 1088can also be positioned as described prior to other portions of thesheets 1082, 1084 being attached to each other. Lastly, while describedas first 1082 and second 1084 sheets, one or both of the sheets cancomprise a group of two or more sheets, such as a series of sheets.

FIG. 4E illustrates a tissue adjustment implant 1110 that includes aplug 1180 that comprises a simple knot tied an end portion 1182 of themain body 1112. Thus, even if a tissue adjustment implant according to aparticular embodiment doesn't initially include a plug, a user can forma plug at or near the time of use, if desired.

FIGS. 6, 6A and 6B illustrate another example of a tissue adjustmentimplant 1200. The tissue adjustment implant 1200 has a main body 1212comprising a substantially flat member extending from a first end 1214to an opposing second end 1216 and having first 1218 and second 1220opposing sides. The main body 1212 has a first 1222 or upper surface andan opposing second 1224 or lower surface. The main body 1212 has alengthwise axis 1226 and a transverse axis 1228 that orthogonallyintersects the lengthwise axis 1226 at a longitudinal midpoint 1230disposed on the lengthwise axis 1226. A first anchor portion 1232 isdisposed on the first end 1214 of the main body 1212 and defines anarrowhead 1280 having a terminal point 1282. First 1284 and second 1286sides of the arrowhead 1280 are oriented at angle 1288 with respect toeach other. In contrast to some of the examples described above, thesecond end 1216 in the example embodiment does not include a plug orother terminal structure, although inclusion of a plug or other suitablestructure may be desirable in certain embodiments.

A series of projections 1238 extends from one side 1218 of the main body1210. The other side 1220 is substantially flat and contains noprojections. Thus, in this embodiment, projections extend from only oneside of the main body 1210. Also, each of the projections in the seriesof projections 1238 extends away from the main body 1210, away from thesecond end 1216. Also, the first 1284 and second 1286 sides of thearrowhead 1280 extend away from the main body 1210 and away from thefirst end 1214.

The main body 1210 includes a throat portion 1290 that transitions fromthe width of the base of the arrowhead 1280 to the width of the mainbody 1210, taken from the first side 1218 to the second side 1220. Theinventors have determined that inclusion of the throat portion 1290provides desirable loading and implantation properties.

The inventors have determined that the inclusion of the arrowhead 1280and the series of projections 1238 on one side 1218 on the tissueadjustment implant 1200 provides desirable anchoring characteristicswhile maintaining a low profile structure that facilitates implantationand retention.

The tissue adjustment implant 1200 can be formed as an integral unitthat defines the main body, series of projections, first anchor portion,and throat portion. In these embodiments, an integral unit formed as amulti-laminate construct, as described below, is consideredadvantageous. Alternatively, the tissue adjustment implant 1200 can beformed as separate portions that are attached or otherwise secured toeach other. For example, a main body can be formed with the projections,and an anchor portion, such as an anchor portion that defines anarrowhead, can be attached or otherwise secured to an end of the mainbody to form a tissue adjustment implant.

FIG. 7 illustrates an alternate tissue adjustment implant 1200′. Thetissue adjustment implant 1210′ according to this embodiment is the sameas the tissue adjustment implant 1200 described above and illustrated inFIGS. 6, 6A, and 6B, except as detailed below. Thus, the tissueadjustment implant 1200′ has a main body 1212′ comprising asubstantially flat member extending from a first end 1214′ to anopposing second end 1216′ and having first 1218′ and second 1220′opposing sides. The main body 1212′ has a first 1222′ or upper surfaceand an opposing second 1224′ or lower surface. The main body 1212′ has alengthwise axis 1226′ and a transverse axis 1228′ that orthogonallyintersects the lengthwise axis 1226′ at a longitudinal midpoint 1230′disposed on the lengthwise axis 1226′. A first anchor portion 1232′ isdisposed on the first end 1214′ of the main body 1212′ and defines anarrowhead 1280′ having a terminal point 1282′. A series of projections1238′ extends from one side 1218′ of the main body 1210′. The other side1220′ is substantially flat and contains no projections. Thus, in thisembodiment, projections extend from only one side of the main body1210′. Also, each of the projections in the series of projections 1238′extends away from the main body 1210′, away from the second end 1216′.Also, the first 1284′ and second 1286′ sides of the arrowhead 1280′extend away from the main body 1210′ and away from the first end 1214′.The main body 1210′ includes a throat portion 1290′ that transitionsfrom the width of the base of the arrowhead 1280′ to the width of themain body 1210′, taken from the first side 1218′ to the second side1220′.

In this embodiment, the terminal point 1282′ of the arrowhead 1280′ is arounded point. Also in this embodiment, the first 1284′ and second 1286′sides of the arrowhead 1280′ are oriented at angle 1288′ with respect toeach other. The angle 1288′ of this embodiment is relatively broad, orobtuse, as compared to the angle 1288 in the embodiment illustrated inFIGS. 6, 6A, and 6B.

In a tissue adjustment implant according to a particular embodiment thatincludes an anchor portion that defines an arrowhead, the sides of thearrowhead can be oriented with respect to each other at any suitableangle. A skilled artisan will be able to determine a suitable angle fora tissue adjustment implant according to a particular embodiment basedon various considerations, including the nature of the tissue withinwhich the tissue adjustment implant is intended to be used, the materialforming the tissue adjustment implant, and other considerations. Theinventors have determined that an acute angle, such as angle 1288illustrated in FIG. 6, facilitates initial passage of the tissueadjustment implant 1280 into tissue during implantation, but provides arelatively low degree of anchoring or resistance to reverse movementfollowing implantation. In contrast, the inventors have determined thatan obtuse angle, such as angle 1288′ illustrated in FIG. 7, requiresadditional force to accomplish the initial passage of the tissueadjustment implant 1280′ into tissue during implantation, but provides arelatively high degree of anchoring or resistance to reverse movementfollowing implantation. Based on these considerations, the a skilledartisan will be able to select a suitable angle for inclusion in atissue adjustment implant according to a particular embodiment.

Examples of suitable angles include an acute angle and an obtuse angle.Acute angles between about 15 degrees and about 90 degrees are alsoconsidered suitable. Acute angles between about 35 degrees and about 90degrees are also considered suitable. Acute angles between about 45degrees and about 90 degrees are also considered suitable. Acute anglesbetween about 55 degrees and about 90 degrees are also consideredsuitable. Acute angles between about 65 degrees and about 90 degrees arealso considered suitable. Acute angles between about 75 degrees andabout 90 degrees are also considered suitable. Acute angles betweenabout 85 degrees and about 90 degrees are also considered suitable. Theinventors have determined that an acute angle of about 45 degreesprovides a desirable balance between the force required to achieveinitial passage of a tissue adjustment implant into tissue duringimplantation and the degree of anchoring or resistance to reversemovement following implantation. Furthermore, the inventors havedetermined that an acute angle of 45 degrees provides a desirablebalance between the force required to achieve initial passage of atissue adjustment implant into tissue during implantation and the degreeof anchoring or resistance to reverse movement following implantation.

Obtuse angles between about 90 degrees and about 105 degrees are alsoconsidered suitable. Obtuse angles between about 90 degrees and about115 degrees are also considered suitable. Obtuse angles between about 90degrees and about 125 degrees are also considered suitable. Obtuseangles between about 90 degrees and about 135 degrees are alsoconsidered suitable. Obtuse angles between about 90 degrees and about145 degrees are also considered suitable. Obtuse angles between about 90degrees and about 155 degrees are also considered suitable. Obtuseangles between about 90 degrees and about 165 degrees are alsoconsidered suitable. The inventors have determined that an obtuse angleof about 135 degrees provides a desirable balance between the forcerequired to achieve initial passage of a tissue adjustment implant intotissue during implantation and the degree of anchoring or resistance toreverse movement following implantation. Furthermore, the inventors havedetermined that an obtuse angle of 135 degrees provides a desirablebalance between the force required to achieve initial passage of atissue adjustment implant into tissue during implantation and the degreeof anchoring or resistance to reverse movement following implantation.

A right angle is also considered suitable. The inventors have determinedthat an angle of about 90 degrees is suitable. Furthermore, theinventors have determined that an angle of 90 degrees is suitable.

FIGS. 8, 9, 10, and 11 illustrate an example delivery device 1300suitable for implanting a tissue adjustment implant in a tissue of apatient, such as the soft palate of a human being. The delivery device1300 comprises a main body 1310 defining a handle 1312 that can begripped by a user. The main body also defines a barrel 1314 that extendsaway from the handle 1312. A cannula 1350 is disposed in the distal end1316 of the main body 1310 such that the cannula 1350 extends away fromthe main body 1310. In the illustrated embodiment, the cannula 1350defines a bend 1352 such that a first portion 1354 of the cannula 1350extends substantially along an axis of the barrel 1314 and a secondportion 1356 of the cannula 1350 extends away from the axis of thebarrel 1314. The second portion 1356 of the cannula 1350 defines a notch1358.

As best illustrated in FIG. 9, the notch 1358 provides an obliqueopening to the lumen 1360 of the cannula 1350. As best illustrated inFIG. 10, a partial circumferential wall 1362 of the cannula 1350 existsin the notch 1358, which a full circumferential wall 1364 of the cannula1350 exists in the portion of the cannula 1350 disposed axially inwardfrom the notch 1358. Also, as best illustrated in FIG. 9, the notch 1358defines a distal tip 1366 suitable for forming an initial punctureopening in tissue during an implantation procedure.

FIG. 12 illustrates the cannula 1350 of delivery device 1300 and thetissue adjustment implant 1200 of FIG. 6 disposed within the lumen 1360of the cannula 1350. As illustrated in the figure, the tissue adjustmentimplant 1200 is positioned within the cannula 1350 such that theterminal point 1282 of the arrowhead 1280 of the tissue adjustmentimplant 1200 is disposed within the notch and axially inward from thedistal tip 1366 of the cannula 1350. A portion of each of the sides1284, 1286 of the arrowhead 1280 of the tissue adjustment implant extendlaterally outward from the cannula 1350. With this configuration, thetissue adjustment implant can be implanted by pushing the cannula 1350,by applying force to the handle of the delivery device, for example,such that the distal tip 1366 punctures the tissue into which the tissueadjustment implant is to be implanted. By continuing to apply force inthis manner, the portions of the sides 1284, 1286 of the arrowhead areforced into the tunnel formed by the cannula 1350. Once the tissueadjustment implant 1200 has been advanced into the tissue to a desirableor suitable distance, the cannula 1350 can be retracted by applying areverse force on the handle of the delivery device. As this isperformed, the sides 1284, 1286 of the arrowhead will engage the tissueand anchor the tissue adjustment implant 1200 in place, allowing thecannula 1350, and the delivery device, to be retracted while leaving thetissue adjustment implant in place.

The tissue adjustment implants can be formed of any suitable material ormaterials, and a skilled artisan will be able to select an appropriatematerial or materials for a tissue adjustment implant according to aparticular embodiment based on various considerations, including thetissue with which the tissue adjustment implant is intended to be used,the technique by which the tissue adjustment implant will be implanted,and other considerations. Both synthetic and natural materials areconsidered suitable. Examples of suitable synthetic materials includepolymeric materials, such as polyethylene, polypropylene and otherflexible polymeric materials. Examples of suitable natural materialsinclude tissue and tissue-derived materials. The inventors havedetermined that tissue adjustment implants formed of bioremodelablematerials are particularly well-suited for implantation within andadjustment of various tissues in human and other animals at leastbecause of the ability of such materials to remodel and becomeincorporated into adjacent tissues over time. These materials canprovide a scaffold onto which cellular in-growth can occur, eventuallyallowing the material to remodel into a structure of host cells, whichaids in the effectiveness of the tissue adjustment implant as along-term support of the tissue being secured.

Particular advantage can be provided by tissue adjustment implants thatincorporate a remodelable collagenous material. Such remodelablecollagenous materials, whether reconstituted or naturally-derived, canbe provided, for example, by collagenous materials isolated from awarm-blooded vertebrate, especially a mammal. Such isolated collagenousmaterial can be processed so as to have remodelable, angiogenicproperties and promote cellular invasion and ingrowth. Remodelablematerials may be used in this context to stimulate ingrowth of adjacenttissues into an implanted construct such that the remodelable materialgradually breaks down and becomes replaced by new patient tissue so asto generate a new, remodeled tissue structure. Such materials areconsidered suitable for use in the main body, projections, and plugportions of tissue adjustment implants.

Suitable remodelable materials can be provided by collagenousextracellular matrix (ECM) materials possessing biotropic properties.For example, suitable collagenous materials include ECM materials suchas those comprising submucosa, renal capsule membrane, dermal collagen,dura mater, pericardium, fascia lata, serosa, peritoneum or basementmembrane layers, including liver basement membrane. Suitable submucosamaterials for these purposes include, for instance, intestinal submucosaincluding small intestinal submucosa, stomach submucosa, urinary bladdersubmucosa, and uterine submucosa. Collagenous matrices comprisingsubmucosa (potentially along with other associated tissues) useful inthe present invention can be obtained by harvesting such tissue sourcesand delaminating the submucosa-containing matrix from smooth musclelayers, mucosal layers, and/or other layers occurring in the tissuesource. For additional information as to some of the materials useful inthe tissue adjustment implants, and their isolation and treatment,reference can be made, for example, to U.S. Pat. Nos. 4,902,508,5,554,389, 5,993,844, 6,206,931, and 6,099,567.

Remodelable ECM tissue materials harvested as intact sheets from amammalian source and processed to remove cellular debris advantageouslyretain at least a portion of and potentially all of the native collagenmicroarchitecture of the source extracellular matrix. This matrix ofcollagen fibers provides a scaffold to facilitate and support tissueingrowth, particularly in bioactive ECM implant materials, such asporcine small intestinal submucosa or SIS (Surgisis® Biodesign™, CookMedical, Bloomington Ind.), that are processed to retain an effectivelevel of growth factors and other bioactive constituents from the sourcetissue. In this regard, when a tissue adjustment implant incorporatesthis sort of material, cells will invade the remodelable material uponimplantation eventually leading to the generation of a newly-remodeled,functional tissue structure.

Submucosa-containing or other ECM tissue used in the tissue adjustmentimplants is preferably highly purified, for example, as described inU.S. Pat. No. 6,206,931 to Cook et al. Thus, preferred ECM material willexhibit an endotoxin level of less than about 12 endotoxin units (EU)per gram, more preferably less than about 5 EU per gram, and mostpreferably less than about 1 EU per gram. As additional preferences, thesubmucosa or other ECM material may have a bioburden of less than about1 colony forming units (CFU) per gram, more preferably less than about0.5 CFU per gram. Fungus levels are desirably similarly low, for exampleless than about 1 CFU per gram, more preferably less than about 0.5 CFUper gram. Nucleic acid levels are preferably less than about 5 μg/mg,more preferably less than about 2 μg/mg, and virus levels are preferablyless than about 50 plaque forming units (PFU) per gram, more preferablyless than about 5 PFU per gram. These and additional properties ofsubmucosa or other ECM tissue taught in U.S. Pat. No. 6,206,931 may becharacteristic of any ECM tissue used in the inventive tissue adjustmentimplants.

A typical layer thickness for an as-isolated submucosa or other ECMtissue layer used in the invention ranges from about 50 to about 250microns when fully hydrated, more typically from about 50 to about 200microns when fully hydrated, although isolated layers having otherthicknesses may also be obtained and used. These layer thicknesses mayvary with the type and age of the animal used as the tissue source. Aswell, these layer thicknesses may vary with the source of the tissueobtained from the animal source. In a dry state, a typical layerthickness for an as-isolated submucosa or other ECM tissue layer used inthe invention ranges from about 30 to about 160 microns when fully dry,more typically from about 30 to about 130 microns when fully dry.

Suitable bioactive agents may include one or more bioactive agentsnative to the source of the ECM tissue material. For example, asubmucosa or other remodelable ECM tissue material may retain one ormore growth factors such as but not limited to basic fibroblast growthfactor (FGF-2), transforming growth factor beta (TGF-beta), epidermalgrowth factor (EGF), cartilage derived growth factor (CDGF), and/orplatelet derived growth factor (PDGF). As well, submucosa or other ECMmaterials when used in the invention may retain other native bioactiveagents such as but not limited to proteins, glycoproteins,proteoglycans, and glycosaminoglycans. For example, ECM materials mayinclude heparin, heparin sulfate, hyaluronic acid, fibronectin,cytokines, and the like. Thus, generally speaking, a submucosa or otherECM material may retain one or more bioactive components that induce,directly or indirectly, a cellular response such as a change in cellmorphology, proliferation, growth, protein or gene expression.

Submucosa-containing or other ECM materials used in a tissue adjustmentimplant can be derived from any suitable organ or other tissue source,usually sources containing connective tissues. The ECM materialsprocessed for use in the inventive tissue adjustment implants willtypically include abundant collagen, most commonly being constituted atleast about 80% by weight collagen on a dry weight basis. Suchnaturally-derived ECM materials will for the most part include collagenfibers that are non-randomly oriented, for instance occurring asgenerally uniaxial or multi-axial but regularly oriented fibers. Whenprocessed to retain native bioactive factors, the ECM material canretain these factors interspersed as solids between, upon and/or withinthe collagen fibers. Particularly desirable naturally-derived ECMmaterials for use in the invention will include significant amounts ofsuch interspersed, non-collagenous solids that are readily ascertainableunder light microscopic examination with appropriate staining. Suchnon-collagenous solids can constitute a significant percentage of thedry weight of the ECM material in certain inventive embodiments, forexample at least about 1%, at least about 3%, and at least about 5% byweight in various embodiments of the invention.

The submucosa-containing or other ECM material used in the inventivetissue adjustment implants may also exhibit an angiogenic character andthus be effective to induce angiogenesis in a host engrafted with thematerial. In this regard, angiogenesis is the process through which thebody makes new blood vessels to generate increased blood supply totissues. Thus, angiogenic materials, when contacted with host tissues,promote or encourage the formation of new blood vessels into thematerials. Methods for measuring in vivo angiogenesis in response tobiomaterial implantation have recently been developed. For example, onesuch method uses a subcutaneous implant model to determine theangiogenic character of a material. See, C. Heeschen et al., NatureMedicine 7 (2001), No. 7, 833-839. When combined with a fluorescencemicroangiography technique, this model can provide both quantitative andqualitative measures of angiogenesis into biomaterials. C. Johnson etal., Circulation Research 94 (2004), No. 2, 262-268.

Further, in addition or as an alternative to the inclusion of suchnative bioactive components, non-native bioactive components such asthose synthetically produced by recombinant technology or other methods(e.g., genetic material such as DNA), may be incorporated into an ECMmaterial used in an inventive tissue adjustment implant. Thesenon-native bioactive components may be naturally-derived orrecombinantly produced proteins that correspond to those nativelyoccurring in an ECM tissue, but perhaps of a different species. Thesenon-native bioactive components may also be drug substances.Illustrative drug substances that may be added to materials include, forexample, anti-clotting agents, e.g. heparin, antibiotics,anti-inflammatory agents, thrombus-promoting substances such as bloodclotting factors, e.g., thrombin, fibrinogen, and the like, andanti-proliferative agents, e.g. taxol derivatives such as paclitaxel.Such non-native bioactive components can be incorporated into and/oronto ECM material in any suitable manner, for example, by surfacetreatment (e.g., spraying) and/or impregnation (e.g., soaking), to namea few. Also, these substances may be applied to the ECM material in apremanufacturing step, immediately prior to the procedure (e.g., bysoaking the material in a solution containing a suitable antibiotic suchas cefazolin), or during or after engraftment of the material in thepatient.

Inventive devices can incorporate xenograft material (i.e.,cross-species material, such as tissue material from a non-human donorto a human recipient), allograft material (i.e., interspecies material,with tissue material from a donor of the same species as the recipient),and/or autograft material (i.e., where the donor and the recipient arethe same individual). Further, any exogenous bioactive substancesincorporated into an ECM material may be from the same species of animalfrom which the ECM material was derived (e.g. autologous or allogeneicrelative to the ECM material) or may be from a different species fromthe ECM material source (xenogeneic relative to the ECM material). Incertain embodiments, ECM material will be xenogeneic relative to thepatient receiving the graft, and any added exogenous material(s) will befrom the same species (e.g. autologous or allogeneic) as the patientreceiving the graft. Illustratively, human patients may be treated withxenogeneic ECM materials (e.g. porcine-, bovine- or ovine-derived) thathave been modified with exogenous human material(s) as described herein,those exogenous materials being naturally derived and/or recombinantlyproduced.

The inventors have determined that SIS is particularly well-suited foruse in the tissue adjustment implant devices described herein at leastbecause of its well-characterized nature and ready availability.Furthermore, the inventors have determined that vacuum-pressed SISprovides a particularly advantageous material from which to form tissueadjustment implant devices that include one or more pluralities ofprojections, such as the tissue adjustment implants described andillustrated herein. Lyophilized SIS can also be used, and may beadvantageous for tissue adjustment implants in which a relativelyquicker remodeling time is desired. Radiopaque SIS can also be used, andmay be advantageous for tissue adjustment implants for which enhancedvisualization characteristics are desired.

The inventors have determined that a tissue adjustment implant having amain body formed of multiple layers laminated together provides aparticularly advantageous structure. Thus, the main body can comprise amultilaminate construct. In these embodiments, any suitable number oflayers can be used, and a skilled artisan will be able to select anappropriate number of layers for a particular tissue adjustment implantbased on various considerations, including the intended use of thetissue adjustment implant and nature of the tissue intended to besupported by the tissue adjustment implant. The inventors havedetermined that a tissue adjustment implant having a main body formed ofbetween 4 and 12 layers of an ECM material, such as SIS, provides aparticularly advantageous structure for tissue adjustment implantsintended for use in supporting the soft palate of a patient, such as inmethods of treating Obstructive Sleep Apnea (OSA). A main body formed ofbetween 6 and 10 layers of an ECM material, such as SIS, is alsoconsidered particularly advantageous. A main body formed of 8 layers ofan ECM material, such as SIS, is also considered particularlyadvantageous. A main body formed of up to 60 layers of an ECM material,such as SIS, is also considered particularly advantageous. In theseembodiments, the layers can be assembled together in any suitable mannerand using any suitable technique or process. For multilaminate SISconstructs, the inventors have determined that vacuum-pressing ofmultiple layers of SIS provides a suitable laminate structure for use asa tissue adjustment implant as described herein. The layers in themultilaminate construct can be vacuum-pressed prior to assembly into themultilaminate construct. Alternatively, the multilaminate construct canbe vacuum-pressed after assembly of the layers. Also alternatively, thelayers can be vacuum-pressed prior to assembly and the assembly can bevacuum-pressed after assembly. The inventors have determined that use ofvacuum-pressed SIS provides desirable durability and profilecharacteristics. When using a vacuum-pressed layers of an ECM material,such as SIS, any suitable number of vacuum-pressed layers can be used.The inventors have determined that a tissue adjustment implant having amain body formed of between 4 and 60 layers provides a particularlyadvantageous structure for tissue adjustment implants intended for usein supporting the soft palate of a patient, such as in methods oftreating OSA. A main body formed of between 10 and 50 layers is alsoconsidered particularly advantageous. A main body formed of between 20and 40 layers is also considered particularly advantageous. A main bodyformed of between 25 and 35 layers is also considered particularlyadvantageous. A main body formed of about 30 layers is also consideredparticularly advantageous. The inventors have determined that a tissueadjustment implant comprising a multilaminate construct comprised of 30layers of vacuum-pressed SIS provides a suitable structure for use inmethods of treating OSA.

The inventors have determined that a hybrid structure may provide adesirable balance between desired overall rigidity for the tissueadjustment implant and relative remodeling time. In this embodiment, amiddle portion of the tissue adjustment implant is formed of lyophilizedSIS, which provides a relatively quicker remodeling time, and theperimeter sections, including the ribbed portions, are formed ofvacuum-pressed SIS, which provides a relatively high degree of overallrigidity. The middle portion in this embodiment is expected to remodelrelatively quickly following implantation, enhancing the securement ofthe tissue adjustment implant. An opposite structure is also consideredsuitable and may be advantageous in certain circumstances.

A hybrid structure in which a mesh is embedded inside an SIS or othercomposition or between layers of SIS or of other material is alsoconsidered suitable. For example, a polymeric mesh, such as a meshformed of polypropylene, can be disposed between layers of SIS duringformation of the tissue adjustment implant. In these embodiments, thepolymeric mesh will remain in the body following completion ofremodeling by the SIS, which may enhance the overall anchoring of thesupported tissue over time. A bioabsorable mesh, such as a mesh formedof polyglycolic acid or other bioabsorbable material, can also beincluded in the tissue adjustment implant in this manner and may beadvantageous where supplemental support is desired that lasts beyond theremodeling time for the SIS, but that does not have the permanencyassociated with a polypropylene or other polymeric mesh. Examples ofsuitable structural arrangements of polymer and remodelable layers canbe found in United States Patent Application Publication No.2011/0166673 to Patel et al., for QUILTED IMPLANTABLE GRAFT, the entirecontents of which are hereby incorporated into this disclosure.

A tissue adjustment implant, or portions thereof, can also be coatedwith particular materials to provide a desired property or properties.For example, the inventors have determined that coating a tissueadjustment implant with poly(lactic-co-glycolic acid) (PLGA) provides adesirable stiffening effect to the implant while also providing an agentthat promotes an inflammatory response in tissue within which the tissueadjustment implant has been placed. In tissue adjustment implants thatcomprise a multilaminate construct, as describe above, a coating can beapplied between layers during fabrication. For example, PLGA can beapplied to or embedded within one, two, a plurality of, or all of thelayers when making a main body that comprise a multilaminate construct.

The tissue adjustment implants are implanted by forming an opening in atarget tissue, passing the first end of the tissue adjustment implantthrough the opening and into the tissue until the plug contacts thetissue surrounding the opening. If desired, additional pulling force canbe applied to the first end to lift or otherwise adjust the position ofthe tissue through interaction with the plug. Once a desired position isachieved, a portion of the tissue adjustment implant, such as a portionnear the first end of the tissue adjustment implant, can be sutured tothe tissue. This is beneficial for maintaining the adjusted position ofthe tissue.

After passing the first end of the tissue adjustment implant through theopening in the tissue and into the tissue, the first end of the tissueadjustment implant, or a lead attached to it, can be manipulated to exitthe tissue, either through an existing opening or by forming an opening,at a point at a distance from the opening through with the tissueadjustment implant entered the tissue. This is particularly advantageousfor tissue adjustment implants that include a lead, such as a needle andsuture attached to a first end of the tissue adjustment implant. Also,if desired, the tissue adjustment implant can be trimmed of excess mainbody such that the remainder of the tissue adjustment implant is flushor substantially flush with the opening through which the tissueadjustment implant exits the tissue. If this is performed, it isadvantageously performed after the tissue adjustment implant is securedto the tissue, if performed, such that any desired adjusted position ofthe tissue is maintained after the trimming is completed.

The tissue adjustment implants are particularly well-suited foradjusting the position of the soft palate of a patient, such as a humanbeing. Such an adjustment may be beneficial in the treatment ofObstructive Sleep Apnea (OSA). FIG. 5 illustrates a schematic of an oralcavity 1300 of a patient within which first 1310 a and second 1310 btissue adjustment implants have been placed. In this example, each ofthe tissue adjustment implants 1310 a, 1310 b comprises a tissueadjustment implant according to the embodiment illustrated in FIGS. 2and 2A. The first tissue adjustment implant 1310 a has been implanted inthe soft palate 1350 on a first side of the uvula 1352 and the secondtissue adjustment implant 1310 b has been implanted in the soft palate1350 on a second, opposite side of the uvula 1352. Each tissueadjustment implant 1310 a, 1310 b has been implanted as described above,such that the respective plugs 1380 a, 1380 b have been buried justbeneath the surface of the tissue of the soft palate 1350. Each tissueadjustment implant 1301 a, 1301 b was pulled taught after the respectiveplugs 1310 a, 1310 b had reached that position to achieve a desiredlifting of the rear portion 1352 of the soft palate. Subsequently, theleads (not illustrated in FIG. 5) were cut and removed from the tissueadjustment implants and the respective first ends 1314 a, 1314 b of thetissue adjustment implants 1310 a, 1310 b were sutured to the tissue ofthe soft palate 1350 to maintain the adjusted position of the softpalate 1350. In FIG. 5, the tissue adjustment implants 1310 a, 1310 b,were implanted by passing the tissue adjustment implants 1310 a, 1310 bthrough an opening made in the tissue toward the rear of the oral cavity1300 and advancing them toward the front of the oral cavity 1300. Whileanother approach can be used, this approach is suitable for tissueadjustment implants having a plug on their distal end, such as tissueadjustment implants 1310 a, 1310 b.

FIG. 13 illustrates another schematic of an oral cavity 1400 of apatient within which first 1410 a and second 1410 b tissue adjustmentimplants have been placed. In this example, each of the tissueadjustment implants 1410 a, 1410 b comprises a tissue adjustment implantaccording to the embodiment illustrated in FIGS. 6, 6A and 6B. The firsttissue adjustment implant 1410 a has been implanted in the soft palate1450 on a first side of the uvula 1452 and the second tissue adjustmentimplant 1410 b has been implanted in the soft palate 1450 on a second,opposite side of the uvula 1452. Each tissue adjustment implant 1410 a,1410 b has been implanted as described above with respect to thedelivery device illustrated in FIGS. 8 through 12. In FIG. 13, thetissue adjustment implants 1410 a, 1410 b, were implanted by passing thetissue adjustment implants 1410 a, 1410 b through an opening made in thetissue toward the front of the oral cavity 1400 and advancing themtoward the rear of the oral cavity 1400. While another approach can beused, this approach is suitable for tissue adjustment implants that lacka plug on their distal end and/or that have an anchor portion, such asthe arrowhead on each of tissue adjustment implants 1410 a, 1410 b, ontheir proximal end, such as tissue adjustment implants 1410 a, 1410 b.

Those with ordinary skill in the art will appreciate that variousmodifications and alternatives for the described and illustratedembodiments can be developed in light of the overall teachings of thedisclosure. Accordingly, the particular arrangements disclosed areintended to be illustrative only and not limiting as to the scope of theinvention, which is to be given the full breadth of the appended claimsand any and all equivalents thereof.

We claim:
 1. A delivery device, comprising: a main body defining ahandle; a cannula extending away from the handle, the cannula defining afirst axial portion, a second axial portion, a notch, and a benddisposed between the first axial portion and the second axial portionsuch that the first axial portion extends substantially along a firstaxis and the second axial portion extends substantially along a secondaxis; a tissue adjustment implant partially disposed in the notch, thetissue adjustment implant comprising: a tissue adjustment implant mainbody extending along a lengthwise axis and having first and secondopposing ends, a longitudinal midpoint, first and second opposing sides,a first width extending from the first side to the second sideorthogonally to the lengthwise axis and through the longitudinalmidpoint, a first anchor portion, a series of projections, and anopening, the first anchor portion extending along the lengthwise axisfrom a point on the lengthwise axis between the longitudinal midpointand the first end to the first end, the first anchor portion having asecond width extending orthogonally to the lengthwise axis, the secondwidth being greater than the first width, the series of projectionsextending along the first side, each projection of the series ofprojections extending away from the second end and the lengthwise axis,the opening defined along the lengthwise axis; and a lead attached tothe tissue adjustment main body.
 2. The delivery device of claim 1,wherein the series of projections comprises a second anchor portionextending along the lengthwise axis of the tissue adjustment implantmain body from a point on the lengthwise axis between the longitudinalmidpoint and the second end to the second end.
 3. The delivery device ofclaim 1, wherein the tissue adjustment implant has a second openingdefined along the lengthwise axis of the tissue adjustment implant mainbody.
 4. The delivery device of claim 1, wherein the series ofprojections extends along the second side.
 5. The delivery device ofclaim 1, wherein the first anchor portion comprises a second series ofprojections extending along the first side, each projection of thesecond series of projections extending away from the first end and thelengthwise axis of the tissue adjustment implant main body.
 6. Thedelivery device of claim 1, wherein the tissue adjustment implantdefines an arrowhead.
 7. The delivery device of claim 6, wherein thearrowhead defines a terminal point; and wherein the terminal pointcomprises a rounded point.
 8. The delivery device of claim 1, whereinthe first anchor portion defines an arrowhead having a first arrowheadside oriented at an angle to a second arrowhead side.
 9. The deliverydevice of claim 8, wherein the angle is an acute angle.
 10. The deliverydevice of claim 8, wherein the angle is an obtuse angle.
 11. Thedelivery device of claim 8, wherein the angle is a right angle.
 12. Thedelivery device of claim 8, wherein the arrowhead defines a terminalpoint; and wherein the terminal point comprises a rounded point.
 13. Thedelivery device of claim 1, further comprising a throat portion thattransitions from the first width to the second width.
 14. The deliverydevice of claim 1, wherein the second side of the first anchor portioncontains no projections.
 15. The delivery device of claim 1, wherein atleast one projection of the series of projections comprises awing-shaped member having a base and an end, the base having a basewidth that extends parallel to the lengthwise axis of the tissueadjustment implant main body and the end having an end width thatextends parallel to the lengthwise axis of the tissue adjustment implantmain body; and wherein the base width is greater than the end width. 16.The delivery device of claim 1, wherein each projection of the series ofprojections comprises a wing-shaped member having a base and an end, thebase having a base width that extends parallel to the lengthwise axis ofthe tissue adjustment implant main body and the end having an end widththat extends parallel to the lengthwise axis of the tissue adjustmentimplant main body and that is less than the base width.
 17. The deliverydevice of claim 1, wherein the tissue adjustment implant comprises abioremodelable material.
 18. The delivery device of claim 17, whereinthe bioremodelable material comprises an extracellular matrix (ECM)material.
 19. A delivery device, comprising: a main body defining ahandle; a cannula extending away from the handle, the cannula defining afirst axial portion, a second axial portion, a notch, and a benddisposed between the first axial portion and the second axial portionsuch that the first axial portion extends substantially along a firstaxis and the second axial portion extends substantially along a secondaxis; a tissue adjustment implant partially disposed in the notch, thetissue adjustment implant comprising: a tissue adjustment implant mainbody extending along a lengthwise axis and having first and secondopposing ends, a longitudinal midpoint, first and second opposing sides,a first width extending from the first side to the second sideorthogonally to the lengthwise axis and through the longitudinalmidpoint, a first anchor portion, a second anchor portion, and anopening, the first anchor portion extending along the lengthwise axisfrom a point on the lengthwise axis between the longitudinal midpointand the first end to the first end, the first anchor portion comprisinga first series of projections extending along the first side, eachprojection of the first series of projections extending away from thefirst end and the lengthwise axis, the first anchor portion having asecond width extending orthogonally to the lengthwise axis, the secondwidth being greater than the first width, the second anchor portionextending along the lengthwise axis from a point on the lengthwise axisbetween the longitudinal midpoint and the second end to the second end,the second anchor portion comprising a second series of projectionsextending along the first side, each projection of the second series ofprojections extending away from the second end and the lengthwise axis,the opening defined along the lengthwise axis; and a lead attached tothe tissue adjustment main body.
 20. A delivery device, comprising: amain body defining a handle; a cannula extending away from the handle,the cannula defining a first axial portion, a second axial portion, anotch, and a bend disposed between the first axial portion and thesecond axial portion such that the first axial portion extendssubstantially along a first axis and the second axial portion extendssubstantially along a second axis; a tissue adjustment implant partiallydisposed in the notch, the tissue adjustment implant comprising: atissue adjustment main body extending along a lengthwise axis and havingfirst and second opposing ends, a longitudinal midpoint, first andsecond opposing sides, and a first width extending from the first sideto the second side orthogonally to the lengthwise axis and through thelongitudinal midpoint, a first anchor portion, a second anchor portion,a first opening, and a second opening, the first anchor portionextending along the lengthwise axis from a point on the lengthwise axisbetween the longitudinal midpoint and the first end to the first end,the first anchor portion comprising a first series of projectionsextending along the first side and containing no projections on thesecond side, each projection of the first series of projectionsextending away from the first end and the lengthwise axis, the firstanchor portion having a second width extending orthogonally to thelengthwise axis, the second width being greater than the first width,the second anchor portion extending along the lengthwise axis from apoint on the lengthwise axis between the longitudinal midpoint and thesecond end to the second end, the second anchor portion comprising asecond series of projections extending along the first side and thesecond side, each projection of the second series of projectionsextending away from the second end and the lengthwise axis, the firstopening defined along the lengthwise axis, the second opening definedalong the lengthwise axis; and a lead attached to the tissue adjustmentmain body.